Revumenib + Mezigdomide for Acute Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if combining mezigdomide and revumenib is a safe treatment for people with certain types of acute leukemia that have returned or resisted other treatments. It focuses on leukemias with specific genetic changes, such as KMT2A, NUP98, or NPM1 mutations, which genetic tests can identify. Suitable candidates for this trial have experienced a relapse or lack of response to previous leukemia treatments and possess one of these genetic markers. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot use strong or moderate CYP3A4 inhibitors or inducers, or proton pump inhibitors within 2 weeks before starting the treatment. Some other medications like hydroxyurea and corticosteroids are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of the drugs revumenib and mezigdomide is being tested for safety in treating certain types of acute leukemia. Early results suggest that revumenib, which blocks a protein called menin, was well-tolerated by patients, even when used with other treatments. This indicates that most people did not experience severe side effects.
The studies aim to understand how these two drugs work together and if they are safe for people with leukemia that has returned or is difficult to treat. Since this research is in the early stages, researchers are carefully monitoring for any side effects. This step-by-step process helps ensure that any potential risks are identified and managed before more people try the treatment.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Revumenib and Mezigdomide for acute leukemia because they target the disease in innovative ways that differ from standard chemotherapy. Revumenib works by inhibiting menin, a protein that plays a role in the development of leukemia, potentially offering a more targeted approach. Mezigdomide is designed to modulate the immune response, which can help the body better fight off cancer cells. These unique mechanisms offer hope for more effective treatments with potentially fewer side effects compared to traditional options.
What evidence suggests that the combination of mezigdomide and revumenib could be an effective treatment for acute leukemia?
Research has shown that combining mezigdomide and revumenib, both under study in this trial, may help treat certain types of acute leukemia. In earlier studies, this combination nearly eliminated leukemia in test models. Revumenib alone demonstrated a 63% success rate in treating similar leukemias and has received FDA approval for some types of acute myeloid leukemia. These findings suggest that using mezigdomide with revumenib could effectively treat relapsed or difficult-to-treat acute leukemias.13678
Who Is on the Research Team?
Eytan Stein, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals aged 12 or older, weighing at least 40 kg, with relapsed/refractory acute leukemia (AML, ALL, or mixed phenotype) after failing at least one treatment. They must have specific genetic changes: NPM1c variants or KMT2A/NUP98 translocations. Phase 2 participants are grouped based on prior menin inhibitor treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1A Treatment
The first cohort of 3 patients will be treated at dose level 1A
Phase 1B Treatment
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients
Phase 1C Treatment
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients
Phase 2 Treatment
Menin Inhibitor Naive Cohort: Up to 24 patients, including up to 6 from phase I
Phase 2 Treatment
Menin Inhibitor Exposed Cohort: Up to 16 patients, including up to 6 from phase I
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mezigdomide
- Revumenib
Trial Overview
The study tests the safety of combining two drugs, Revumenib and Mezigdomide, for people with certain genetic types of acute leukemias that haven't responded to previous treatments. It aims to determine if this drug combination can be an effective therapy.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
In the menin-inhibitor naïve cohort, there will be up to 24 patients, including up to 6 patients from the phase I portion of the study
In the menin-inhibitor exposed cohort, there will be up to 16 patients, including up to 6 patients from the phase I portion of the study
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
The next cohort of patients will not be treated until toxicity has been evaluated in the current cohort of patients.
The first cohort of 3 patients will be treated at dose level 1A
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
Mezigdomide is effective alone and in combination with ...
Remarkably, mezigdomide in combination with revumenib nearly entirely cleared the leukemia (Figure 6A; supplemental Figure 6A-B). In the DFAM-22359 PDX (NPM1c) ...
NCT07356154 | A Study of Revumenib and Mezigdomide ...
The purpose of this study is to find out whether the combination of mezigdomide and revumenib is a safe treatment for people with relapsed ...
3.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/1657/554529/A-Phase-1-2-study-of-the-menin-inhibitor-revumenibA Phase 1/2 study of the menin inhibitor revumenib with the ...
Data is limited, but outcomes after MENINi failure appear poor and few targeted options exist beyond initial MENINi treatment. IKAROS, a key ...
A Phase 1/2 study of the menin inhibitor revumenib with ...
Revumenib, the first FDA-approved MENINi, achieved a 63% ORR and 21% CR/CRh rate in R/R KMT2Ar acute leukemias the AUGMENT-101 study (Issa, ...
5.
oncologynewscentral.com
oncologynewscentral.com/drugs/info/fda-approves-revumenib-for-acute-myeloid-leukemia-with-susceptible-npm1-mutationFDA Approves Revumenib for Acute Myeloid Leukemia ...
With a median follow-up of 6.1 months in the efficacy population, the overall response rate (ORR) was 63%, with 23% of patients having a CR or ...
6.
ctsearchsupport.org
ctsearchsupport.org/clinical-trials/a-study-of-revumenib-and-mezigdomide-in-people-with-leukemiaNMDP℠ CTSS
... mezigdomide and revumenib is safe and works well to treat acute leukemia that is mutated and has relapsed or is refractory in children and
7.
ir.syndax.com
ir.syndax.com/news-releases/news-release-details/syndax-highlights-leadership-menin-inhibition-ash-2025-multipleSyndax Highlights Leadership in Menin Inhibition at ASH ...
Along with excellent clinical activity, we observed that Revuforj was well-tolerated, including in combination with other therapies,” said David ...
Revumenib + Mezigdomide for Acute Leukemia
The study tests the safety of combining two drugs, Revumenib and Mezigdomide, for people with certain genetic types of acute leukemias that ...
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